enVVeno Medical Posts $6.29 Q3 Loss Per Share, Targets Year-End Enrollment

enVVeno Medical posted a $4.4 million third-quarter loss and expects to begin TAVVE study enrollment before year-end, advancing clinical testing of its investigational replacement venous valve.

The net loss was $4.4 million, or $6.29 per basic and diluted share, for the quarter ended Sept. 30. In the same quarter a year earlier, the company had a $4.5 million loss, or $7.89 per share. Operating expenses totaled $4.5 million, down from $4.9 million.

CEO Robert Berman said, “We are on schedule to enroll our first patient before the end of the year.” The first stage is expected to include up to 10 patients.

After collecting 30-day safety data from those patients, enVVeno plans to submit the information to the Food and Drug Administration (FDA) before seeking to enroll a second stage. That stage would include 220 randomized patients: 165 assigned to the enVVe System and 55 to a control group. The second stage remains subject to FDA requirements. The study is being conducted under an FDA-approved Investigational Device Exemption.

The enVVe System is a catheter-delivered replacement venous valve in development for severe deep venous disease. It is investigational and has not been approved or cleared for any indication in any market.

As of Sept. 30, enVVeno held about $18.5 million in cash and investments, comprising $2.6 million in cash and cash equivalents and $15.9 million in short-term investments. The company believes those resources will fund operations into the fourth quarter of 2027.

Cash burn was $3 million in the quarter. enVVeno expects quarterly cash burn to rise to $4 million to $5 million in the first half of 2027 as patient enrollment progresses.